Ethical Conduct of Clinical Research Involving Children (2004) / Chapter Skim
Currently Skimming:
Appendix C: Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research
Appendix C: Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research
Pages 388-393
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 388... ...
. For research involving only medical records or stored biological samples, the primary issue in protecting research participants involves threats to privacy.
|
From page 389... ...
The law does not require permission from patients for health care providers, health plans, and health care clearinghouses to use information as part of their normal activities of providing health care or administering health benefits. For other purposes, including research, the law requires a specific, written authorization for covered organizations to release personal information that is protected under the law.
|
From page 390... ...
Among researchers studying adolescents, there is some concern that parents may have access to information about adolescents that would otherwise be held confidential. The final HIPAA regulations defer to state laws on parental access to the health records of minors.
|
From page 391... ...
published policies on investigator financial conflicts of interest involving research funded by these agencies (NIH, 2000) .1 A recent review by NIH of institutional conflict-of-interest policies revealed considerable variation and some deficits, particularly in the clarity of policies for reporting conflicting interests (NIH, 2002)
|
From page 392... ...
No federal regulations apply directly to institutional conflicts of interest. In interim guidance on financial relationships in clinical research, the U.S.
|
From page 393... ...
2001. Draft Interim Guidance: Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider When Dealing With Issues or Financial Interest and Human Subject Protection.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.